NCT05183854RecruitingPhase 2
Pneumococcal Pneumonia Vaccine Series (PCV20 and PPSV23) in Patients With Chronic Lymphocytic Leukemia Associated Immunodeficiency, PROTECT CLL Trial
Phase II Study of the Efficacy of the Pneumococcal Pneumonia Vaccine Series in Patients With Chronic Lymphocytic Leukemia Associated Immunodeficiency (PROTECT CLL)
Source: ClinicalTrials.gov · Last updated 9 Apr 2026
Brief summary (registry, in English)
This phase II trial tests whether the pneumococcal pneumonia vaccine series (PCV20 and PPSV23) works to mount an effective immune response in patients with chronic lymphocytic leukemia. PCV20 and PPSV23 are both vaccines that protect against bacteria that cause pneumococcal disease. Giving these vaccinations as series may make a stronger immune response and prevent against pneumococcal infections in patients with chronic lymphocytic leukemia. This is a single-center trial, conducted at Huntsman Cancer Institute.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 61 (estimated)
- First submitted
- 21 Dec 2021
- Start date
- 31 Jan 2022
- Primary completion date
- Mar 2027
- Lead sponsor
- University of Utah
- Diseases
- Chronic lymphocytic leukaemia
- NCT number
- NCT05183854
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 61
- From 31 Jan 2022 to the primary completion date, Mar 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Subjects who have experienced a severe allergic reaction to prior pneumococcal vaccination.
- Subjects who have received a PCV13 or PCV20 pneumococcal vaccination in the last five years.
- If they have received PPSV23 in ≥ 1 year and no other pneumococcal vaccine they may be included.
- Current or prior use of immunosuppressive medication within 14 days of cycle one day one, EXCEPT for the following permitted steroids:
- Intranasal, inhaled, topical steroids, eye drops or local steroid injection (e.g., intra-articular injection);
- Systemic corticosteroids at physiologic doses =\< 10 mg/day of prednisone or equivalent;
- Steroids as premedication for hypersensitivity reactions (e.g., computed tomography \[CT\] scan premedication).
- Concurrent illness or condition, which, in the opinion of the treating investigator, would negatively impact the subject's study participation.
Other illness
- Active infection requiring systemic antibiotic therapy.
Who the study is looking for
- NAIVE COHORT: Subjects must have a confirmed diagnosis of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) (collectively referred to as CLL throughout) according to the 2018 International Workshop on CLL.
- NAIVE COHORT: Male or female subject aged \>= 18 years.
- NAIVE COHORT: Subjects must not have received prior therapy for CLL.
- VENETOCLAX-TREATMENT COHORT: Subjects must have a confirmed diagnosis of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) (collectively referred to as CLL throughout) according to the 2018 International Workshop on CLL.
- VENETOCLAX-TREATMENT COHORT: Subjects must have received venetoclax (any dose) for at least 12 months with the last dose =\< 12 months prior to registration.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Huntsman Cancer Institute/University of Utah Coordinator of this site? Confirm its status | Salt Lake City | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.